BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSA SILICONE FOLEY CATHETER

    MDR report key: 7510805 · Received May 14, 2018

    Report

    Report Number
    1820334-2018-01319
    Event Type
    Malfunction
    Date Received
    May 14, 2018
    Date of Event
    April 26, 2018
    Report Date
    July 3, 2018
    Manufacturer
    COOK INC
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K): K091767. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: THE UNIVERSA SILICONE FOLEY CATHETER HAS NOT BEEN RETURNED FOR AN EVALUATION AND NO PHOTOGRAPHS WERE PROVIDED FOR REVIEW. WITHOUT THE COMPLAINT DEVICE, A PHYSICAL INVESTIGATION WAS NOT ABLE TO BE COMPLETED. A REVIEW OF THE INSTRUCTIONS FOR USE, QUALITY CONTROL DATA AND SPECIFICATIONS WAS CONDUCTED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT ABLE TO BE PERFORMED AS THE DEVICE LOT NUMBER WAS NOT PROVIDED. A REVIEW FOR ADDITIONAL COMPLAINTS RELATED TO THIS DEVICE LOT COULD NOT BE COMPLETED WITHOUT THE DEVICE LOT NUMBER. THE INSTRUCTIONS FOR USE SUPPLIED WITH THIS DEVICE CONTAINS THE FOLLOWING WARNINGS AND PRECAUTIONS: WARNINGS -DO NOT USE PETROLEUM-BASED OINTMENTS OR LUBRICANTS SINCE THEY MAY DAMAGE SILICONE AND BURST BALLOONS. -ALWAYS INFLATE THE BALLOON WITH A STERILE LIQUID. NEVER INFLATE WITH AIR, CARBON, DIOXIDE OR ANY OTHER GAS. -DO NOT OVERINFLATE. USING EXCESSIVE PRESSURE TO INFLATE THE BALLOON ON THIS DEVICE CAN CAUSE THE BALLOON TO RUPTURE. PRECAUTIONS -WHEN INFLATING THE BALLOON, USE A LUER SYRINGE. DO NOT USE A NEEDLE. -SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ENSURE THAT ALL BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT. HOW SUPPLIED = STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. BASED ON THE PROVIDED INFORMATION A DEFINITIVE CAUSE FOR THE REPORTED ISSUE CANNOT BE ESTABLISHED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS FITTED WITH A UNIVERSA SILICONE FOLEY CATHETER ON THE MORNING OF (B)(6) 2018. AS REPORTED, THE BALLOON WAS INFLATED AT 5CC AND FOUND IN THE PATIENT¿S GARMENT ON (B)(6) 2018. A NEW CATHETER WAS PLACED ON (B)(6) 2018 AND THE BALLOON AGAIN INFLATED AT 5CC. THE FACILITY HAS REPORTED THE DEVICE HAS BEEN DISCARDED AND WILL NOT BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT¿S STATUS, DETAILS OF DEVICE PREPARATION AND PLACEMENT.

    Description of Event or Problem · 1

    USER INFLATED BALLOON WITH PPI WATER USING A SYRINGE. LUBRICANT USED IS OPTILUBE. THE SECOND UNIVERSA SILICONE FOLEY CATHETER ALSO FAILED AS IT DID NOT FIT THE PATIENT. A SEPARATE REPORT WILL BE FILED TO CAPTURE THE SECOND DEVICE FAILURE.

    Description of Event or Problem · 1

    NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353287 UNIVERSA SILICONE FOLEY CATHETER EZL CATHETER, RETENTION TYPE, BALLOON EZL COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1